Title: Serial Release - Mai i lock Management) in LSRTIS
Release Date: 20 May 2021 Document Number: CVB-WI-0085.02

USDA
a7

Heat niapection Serial Release - Mandatory 2008 Review (Mock Management) in

Veterinary Services LSRTIS

Center for Veterinary
Biologics

CONTROLLED//PROPIN//BASIC

1920 Dayton Avenue
PO Box 844
Ames, IA 50010

(515) 337-6100

Document Number: CVB-WI-0085 Revision: 02
Previous Number: ICWI0054.01

Vault: CVB-Released

Section/Area: CVB-WI-IC

Effective Date: 20 May 2021

Notes:

7 lon 24 May 2021, 09:55:53 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Serial Release - Mandatory 2008 Review (Mock Management) in LSRTIS
Release Date: 20 May 2021 Document Number: CVB-WI-0085.02
CONTROLLED//PROPIN//BASIC

Serial Release - Mandatory 2008 Review (Mock Management) in LSRTIS
Source Document: CVB-SOP-0032, Processing Serial Records

Mock check determinations are maintained within the LSRTIS module, under the Serial Release
heading, Mandatory 2008 Review Mgmt. The mandatory 2008 review is performed by the
Biologics Compliance Assistant (BCA).

Criteria for a Mandatory 2008 Review include:

e Program diseases

¢ Products/fractions with a long term review hold (longer than 3-6 months) should be
transferred to a Mandatory 2008 Review

e Newly licensed products —at least 1 year post licensure or a minimum of 3 serials
produced with no compliance issues

o Newly licensed products with tracking types of Breakout — uncomplicated, Split
Manufacture, or For Further Manufacture do not need to be mandatory mock
checked.

Serial specific items, short term review, or those with specific release criteria (i.e., bench record
review) should be entered as Review Holds, and not Mandatory 2008 Review. Comments will
not show up in the Serial Release Action Sheet. Therefore, it is implied that a review against the
outline of production will be sufficient for the BCAs.

I SPECIALIST: To enter a Mandatory 2008 Review (100% mock check)
a. Within LSRTIS, Serial Release module, Click on “Mandatory 2008 Review
Mgmt” subheading
b. Click on “+ Create Mandatory 2008 Review” in the left margins
c. Enter the known/relevant info (non-mandatory fields)
i. Establishment
ii. Product
iii, Agent
iv. Reason
v. Comments
d. Click on the “Create” button

At this point the Mandatory 2008 Reviews are active.

Once a 2008, that meets the criteria entered under Mock Management, has been logged in and
pushed past BCA Initial Review tab in the Serial Release dashboard, then it should be grouped
within the “Mandatory” category of the 2008 Review tab.

CVB-WI-0085.02 Page | of 2

mn 24 May 2021, 09:55:53 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Serial Release - Mandatory 2008 Review (Mock Management) in LSRTIS
Release Date: 20 May 2021 Document Number: CVB-WI-0085.02
CONTROLLED//PROPIN//BASIC

Il. To Modify a Mandatory 2008 Review:
a. Under Mandatory 2008 Review Search, search on the known criteria of the hold:
i. Establishment
ii. Product
iii, Agent
iv. Reason
v. Active?
b. Click on the “Search”
c. Inresults Area, Click on “Show” icon
d. To Edit a record:
i. Click on the “Edit” icon
ii. Update the information within the Mandatory Aphis 2008 Review Screen
iii. Click on “Update” icon

Ill. To Inactivete a record:
a. SPECIALIST:
i. Provide justification for removal
ii. Submit to Product Specialist or Section Leader for Removal
b. PRODUCT MANAGER OR SECTION LEADER:
i. Within LSRTIS, Click on the “Edit” icon
ii. Choose the toggle under "Active" to remove the check mark
iii. Click on "Update" icon

IV. Mandatory 2008s Reviews that are entered in the system, may be reviewed by the
Product Manager (or those acting in their capacity) quarterly; but at least annually.

CVB-WI-0085.02 Page 2 of 2

mn 24 May 2021, 09:55:53 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100